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A single-center, randomized, open-label, three-period and three-crossover trial design is adopted in the single-dose pharmacokinetic study. 12adult volunteers, are assigned to 3 groups, B1(250mg), B2 (500mg), and B3 (1000mg). Each group of subjects receive single-dose test drug at different dosages in each period.
The tolerability and pharmacokinetic studies are performed simultaneously. Two doses, 250 mg and 500 mg, are proposed for multiple-dose tolerability and pharmacokinetic studies. The subjects are divided into two groups, C1 and C2, 12 subjects in each group, half males and half females. 250 mg group is performed first. Each subject receives only one dose, intravenous drip, once daily, for 7 consecutive days
A single-center, randomized, open-label, three-period and three-crossover trial design is adopted in the single-dose pharmacokinetic study. Twelve healthy adult volunteers, half male and female, are enrolled and randomly assigned to three groups, B1, B2, and B3. The subjects in three groups receive three doses, 250 mg, 500 mg and 1000 mg. Each group of subjects receive single-dose test drug at different dosages in each period.
A single-center, randomized, open- label, and dose escalation trial design is used in the multiple-dose tolerability and pharmacokinetic studies. The tolerability and pharmacokinetic studies are performed simultaneously. Two doses, 250 mg and 500 mg, are proposed for multiple-dose tolerability and pharmacokinetic studies. The subjects are divided into two groups, C1 and C2, 12 subjects in each group, half males and half females. 250 mg group is performed first. After completion of observation and confirming that the drug can be safely tolerated, study on 500 mg group is then performed. Each subject receives only one dose, intravenous drip, once daily, for 7 consecutive days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Banapenem B1 group | Experimental | Dose in the 1st period 250mg; Dose in the 2nd period 500mg; Dose in the 3rd period 1000mg |
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| Banapenem B2group | Experimental | Dose in the 1st period 500mg; Dose in the 2nd period 1000mg; Dose in the 3rd period 250mg |
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| Banapenem B3group | Experimental | Dose in the 1st period 1000mg; Dose in the 2nd period 250mg; Dose in the 3rd period 500mg |
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| Banapenem C1group | Experimental | 250mg Once daily for 7 consecutive days |
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| Banapenem C2group | Experimental | 500mg Once daily for 7 consecutive days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Banapenem | Drug | Twelve healthy adult volunteers, half male and female, are enrolled and randomly assigned to three groups, B1, B2, and B3. The subjects in three groups receive three doses, 250 mg, 500 mg and 1000 mg. Each group of subjects receive single-dose test drug at different dosages in each period. The subjects are divided into two groups, C1 and C2, 12 subjects in each group, half males and half females. 250 mg group is performed first. After completion of observation and confirming that the drug can be safely tolerated, study on 500 mg group is then performed |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-24) of Benapenem | AUC(0-24) is the area under the curve from time 0 to 24 hours | Pre dose and 0.25,0.5,0.75,1,1.5, 2, 2.5, 3, 4, 6,8,12, 24,36,48 hours after Dosing |
| Maximum observed plasma concentration (Cmax) of Benapenem | Maximum observed plasma concentration (Cmax) of following in healthy subjects | Pre dose and 0.25,0.5,0.75,1,1.5, 2, 2.5, 3, 4, 6,8,12, 24,36,48 hours after Dosing |
| Time to maximum observed plasma concentration (tmax) of Benapenem | Time to maximum observed plasma concentration (tmax) | Pre dose and 0.25,0.5,0.75,1,1.5, 2, 2.5, 3, 4, 6,8,12, 24,36,48 hours after Dosing |
| Time to elimination half-life (t1/2) of Benapenem | Time to elimination half-life (t1/2) | Pre dose and 0.25,0.5,0.75,1,1.5, 2, 2.5, 3, 4, 6,8,12, 24,36,48 hours after Dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with clinically significant findings in vital signs | Vitals signs such as systolic and diastolic blood pressure, heart rate, and pulse rate will be measured in a semi-supine position after 5 minutes of rest | Screening and Day1, Day 2, Day4 after dosing |
| Number of subjects with clinically significant findings in laboratory parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuan Lv, PhD | Peking University First Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30617093 | Derived | Zhao CY, Lv Y, Zhu Y, Wei MJ, Liu MY, Ji XW, Kang ZS, Xia YH, Tian JH, Ma Y, Liu Y. A First-in-Human Safety, Tolerability, and Pharmacokinetics Study of Benapenem in Healthy Chinese Volunteers. Antimicrob Agents Chemother. 2019 Feb 26;63(3):e02188-18. doi: 10.1128/AAC.02188-18. Print 2019 Mar. |
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there is no plan to make individual participant data to other researchers.
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A single-center, randomized, open-label, three-period and three-crossover trial design is adopted in the single-dose pharmacokinetic study; A single-center, randomized, open- label, and dose escalation trial design is used in the multiple-dose tolerability and pharmacokinetic studies
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Hematology and Clinical Chemistry and Urine routine abnormalities will be monitored |
| Screening and Day1, Day 2, Day4 after dosing |
| Number of subjects with adverse events and serious adverse events | Screening and Day1, Day 2, Day4 after dosing |
| Number of subjects with clinically significant 12-lead ECGs | Single 12-lead ECGs will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, and QT intervals. | Screening and Day1, Day 2, Day4 after dosing |